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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Review Letter - Novoeight

Our STN:  BL 125466/0

Novo Nordisk Inc.
Attention: Mr. Robert B. Clark
P.O. Box 846
Plainsboro, NJ  08536

Dear Mr. Clark:

This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated October 15, 2012 for Antihemophilic Factor (Recombinant), Plasma/Albumin-Free (NovoEight), to determine its acceptability for filing.  Under 21 CFR 601.2(a) we have filed your application today.  The review classification for this application is Standard.  Therefore, the review goal date is October 16, 2013.  This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.

We are reviewing your application according to the processes described in the Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products.  Therefore, we have established internal review timelines as described in the guidance, which include the timeframes for FDA internal milestone meetings.  We plan to hold our internal mid-cycle review meeting on April 4, 2013.  Please be aware that the timelines described in the guidance are flexible and subject to change based on workload and other potential review issues (e.g., submission of amendments).  We will inform you of any necessary information requests or status updates following the milestone meetings or at other times, as needed, during the process.

We will contact you regarding your proposed labeling no later than September 16, 2013.  If post marketing study commitments (506B) are required, we will contact you no later than September 16, 2013.

At this time, we have no plans to present this application to an Advisory Committee.

At this time, we have not identified any potential review issues.  Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application.  Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
 

If you have any questions, please contact the Regulatory Project Manager, Leigh Pracht, at (301) 827-6116.

Sincerely yours, 

Iliana Valencia, MS
Chief
Regulatory Project Management Branch
Office of Blood Research and Review
Center for Biologics
  Evaluation and Research